Randox recalls Urinalysis Control Level 2 (UC5034) due to incorrect leukocyte range for Siemens Multistix tests. This may cause inaccurate urine test results. Affected lots: 1020UC (exp. 28 May 2020).
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Randox is recalling its Urinalysis Control Level 2 (UC5034) because the leukocyte range for Siemens Multistix tests is incorrect. This could lead to inaccurate urine test results if used in routine diagnostics. The recall affects specific lots produced in 2020.
The control product has an incorrect leukocyte range for Siemens Multistix tests. This means it might give false results when used to check urine samples, potentially leading to inaccurate diagnoses.
Healthcare professionals using urine test strips for in vitro diagnostics may be affected. Those using the control product for quality checks on urine tests are most at risk.
Check for the product name 'Randox Urinalysis Control Level 2' with reference number UC5034. The affected lot number is 1020UC, expiring 28 May 2020.
Verify the lot number and expiration date on the product label. The affected lot is 1020UC with an expiration date of 28 May 2020.
The product is not safe for use as it has an incorrect leukocyte range for Siemens Multistix tests, which could lead to inaccurate results.
The official recall notice does not specify a remedy, so contact Randox Laboratories Ltd. for guidance.
Look for the product name 'Randox Urinalysis Control Level 2' with reference number UC5034 and lot number 1020UC expiring 28 May 2020.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2557-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-2557-2019 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
